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Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Technical data obtained through valid experimental methods, and held by the manufacturer. Practical handling experience has not resulted in the questioning of the accuracy of this data.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)

Principles of method if other than guideline:

Seive

GLP compliance:

no

Type of method:

sieving

Type of particle tested:

primary particle

Type of distribution:

mass based distribution

Specific details on test material used for the study:

Lot 48657.

Key result

Percentile:

D95

Mean:

99.68 other: % excluded from filtering through 106 micron mesh

St. dev.:

0

Remarks on result:

other: no data

Remarks:

no data on standard deviation

No.:

#1

Size:

>= 1 400 µm

Distribution:

79.53 %

No.:

#2

Size:

>= 1 000 µm

Distribution:

84.59 %

No.:

#3

Size:

>= 850 µm

Distribution:

86.76 %

No.:

#4

Size:

>= 106

Distribution:

>= 98.55 - <= 99.68 %

Remarks on result:

other: Exclusion % = 99.68

99.68% of particles were excluded from filtering through 106 micron mesh.

Conclusions:

Molecular sizing of the solid particles of the test substance was investigated using the seive method. The fraction of material with particle size greater than 100 microns is 99.68%.

Reference 2

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Technical data obtained through valid experimental methods, and held by the manufacturer. Practical handling experience has not resulted in the questioning of the accuracy of this data.

Qualifier:

equivalent or similar to guideline

Guideline:

other: ASTM 11:61

Principles of method if other than guideline:

Seive sizing of solid particles with Malvern apparatus

GLP compliance:

no

Type of method:

sieving

Type of particle tested:

primary particle

Type of distribution:

mass based distribution

Specific details on test material used for the study:

Lot 48657.

Key result

Percentile:

D95

Mean:

697.922 µm

St. dev.:

0

Remarks on result:

other: no data

Remarks:

no data on standard deviation

Percentile:

D50

Mean:

270.582 µm

St. dev.:

0

Remarks on result:

other: no data on standard deviation

Percentile:

D10

Mean:

76.072 µm

St. dev.:

0

Remarks on result:

other: no data on standard deviation

50% were 270.6 microns. Only 10% were 76.072 microns or smaller.

Detailed Findings:

Concentration: 0.2007 %

Span: 2.298

Uniformity 0.709

Specific surface area: 0.0519 m2/g

Weighted surface mean D[3,2]: 115.548 microns

Vol. Weighted meanD[4,3]: 339.436 microns

Density: 1.000 g/cm2

Conclusions:

Molecular sizing of the solid particles of the test substance was investigated using a Malvern particle sizer. The fraction of material with particle size greater than 100 microns is 15.11%. The DT50 was 271 microns, the DT10 was 76 microns.

Description of key information

99% of particles are larger than 100 µm.

Additional information

Particle size of solid showed 99.7% was larger than 100 µm using a manual seive; the average size of those less than 1000 µm (15%) was 271 µm, as examined in a Malvern particle sizer.